Bioequivalence and Bioavailability Forum • IMP handling

IMP handling [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2017-05-09 03:08 (2805 d 22:31 ago) – Posting: # 17330
Views: 31,268

Hi mittyri,

❝ I suppose the problem could be not in the case of 'significant separation in time' but in case of some mistakes in IMP handling.

❝ For example, RIMP has a proven stability up to 30C and TIMP up to 25 only. Due to some "why bother" attitude the designated employee missed it. As a result the second group will be treated with poor TIMP. I assume here that the order of groups treatment is

❝ GR1PER1

❝ GR1PER2

❝ GR2PER1

❝ GR2PER2

That’s what I would call a “stacked approach”.
IMHO, not a good idea for single dose but might be necessary in steady state studies if the capacity of the clinical site is limited.

❝ The CRO's are usually mixing the time for groups for more effective time management.

Yep – the “staggered approach” keeps the interval as short as possible.

60% of my data sets had an interval of less then seven days. In most of my single dose studies the interval was one to three days.

❝ So I think in case of appropriate IMP handling we wouldn't observe any real (not false-positive) interaction.

Agree.

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Complete thread:

Russian «Экспертами» and their hobby Helmut 2017-04-29 00:46 [Regulatives / Guidelines]
- Low power of Group-by-Treatment interaction mittyri 2017-04-29 22:57
  - Let’s forget the Group-by-Treatment interaction, please! Helmut 2017-04-30 13:54
    - Let’s forget the Group-by-Treatment interaction, please! ElMaestro 2017-05-01 16:19
      - Some answers Helmut 2017-05-02 01:10
        
        Some answers ElMaestro 2017-05-02 09:04
        
        Example Helmut 2017-05-02 12:35
        
        Sensitivity of term? mittyri 2017-05-02 18:29
        
        Simulations Helmut 2017-05-05 14:38
        
        loosing specificity due to low sensitivity mittyri 2017-05-08 23:28
        
        loosing specificity due to low sensitivity Helmut 2017-05-09 00:55
        
        Loss in power Helmut 2017-05-06 17:31
        Interval between groups Helmut 2017-05-08 19:02
        
        IMP handling mittyri 2017-05-08 23:40
        
        IMP handlingHelmut 2017-05-09 01:08
        
        Loss in power Helmut 2017-05-14 17:22
      - No convergence in JMP and Phoenix WinNonlin Helmut 2017-05-25 15:26
        
        Ouch?!??? ElMaestro 2017-05-25 16:24
- Russian «Экспертами» and their hobby Artem Gusev 2017-05-02 16:13
  - be careful with mixed models mittyri 2017-05-02 17:53
    - be careful with mixed models Artem Gusev 2017-05-03 11:02
  - p-value(s) in model 2 Helmut 2017-05-05 14:48
- Russian «Экспертами» following the EEU GLs Helmut 2017-05-24 20:17
  - Russian «Экспертами» following the EEU GLs Beholder 2017-05-24 22:37
    - Penalty for carelessness mittyri 2017-05-25 08:52
    - Russian «Экспертами» following the EEU GLs Beholder 2017-05-25 10:43
  - Russian «Экспертами» following the EEU GLs Mikalai 2018-01-04 10:43
    - Belarus = member of the EEU Helmut 2018-01-04 13:08
      - Belarus = member of the EEU Mikalai 2018-01-04 19:49
      - Trying your model for EEU mittyri 2018-01-04 22:04
        
        Trying your model for EEU Helmut 2018-01-05 00:06
        
        help us to stop it, please... Astea 2018-01-10 12:09
        
        help us to stop it, please... Beholder 2018-01-10 12:49
        regulators convinced by science? d_labes 2018-01-10 15:15
        
        regulators convinced by science? Beholder 2018-01-10 17:14
        
        Чёрт побери! d_labes 2018-01-10 18:53
        
        regulators convinced by science? Astea 2018-01-10 19:10
        
        Excuse me d_labes 2018-01-10 20:18
        
        Excuse me Astea 2018-01-10 20:38